FDA POSTS INFORMATION ON RECENTLY APPROVED DIAGNOSTIC PRODUCTS

The FDA Aug. 30 posted information on two recently approved diagnostic products.

The Monolisa anti-HBs enzyme immunoassay and accompanying anti-HBs calibrator kit, manufactured by Bio-Rad Laboratories, were approved Aug. 25.

The products are used to detect antibodies associated with hepatitis B virus (HBV) infection to determine if a patient has been infected with HBV or is immune to HBV infection, the FDA said.

The approval letter for the products can be viewed at www.fda.gov/cdrh/pdf5/p050048a.pdf (http://www.fda.gov/cdrh/pdf5/p050048a.pdf).